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Statins and Endothelial Function in Patients With Coarctation of the Aorta

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ClinicalTrials.gov Identifier: NCT00767572
Recruitment Status : Terminated (low enrollment)
First Posted : October 7, 2008
Results First Posted : October 14, 2013
Last Update Posted : October 14, 2013
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Coarctation of the Aorta
Interventions Drug: atorvastatin
Drug: Sugar pill
Enrollment 12
Recruitment Details Patients were recruited from the UCSF Adult Congenital Heart Disease Clinic between July 2008 and July 2009. All reviewed the study protocol and agreed to participate. There was no compensation for study participants.
Pre-assignment Details Patients were excluded if they did not have prior repair of aortic coarctation or could not participate in all 4 study visits.
Arm/Group Title Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin
Hide Arm/Group Description Patients were randomized to atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment was performed before and after each 12 week intervention.
Period Title: First Intervention (12 Weeks)
Started 12
Completed 12
Not Completed 0
Period Title: Washout (4 Weeks)
Started 12
Completed 12
Not Completed 0
Period Title: Second Intervention (12 Weeks)
Started 12
Completed 12
Not Completed 0
Arm/Group Title Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin
Hide Arm/Group Description Patients were randomly assigned to receive atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment were performed before and after each 12 week intervention.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
35  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
4
  33.3%
Male
8
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Pre-post Change in Brachial Artery Reactivity
Hide Description Brachial artery reactivity was assessed by Flow-mediated dilatation (FMD), performed before and after the 12 week period on therapy. FMD uses high-frequency ultrasound measurement of changes in brachial artery diameter after a 5-minute blood pressure cuff arterial occlusion. Brachial artery reactivity has been shown to predict long-term cardiovascular events.
Time Frame Baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
12 enrolled participants were randomly assigned to receive a 12-week course of either atorvastatin or placebo, followed by a 4-week washout, then 12 weeks on the alternate intervention.
Arm/Group Title Atorvastatin Sugar Pill
Hide Arm/Group Description:
Patients are randomized to either atorvastatin or placebo once daily for 12 weeks. There is a 4 week washout, and then the groups are switched for 12 weeks.
See above. Patients will be randomized to atorvastatin vs. placebo for 12 weeks and after a 4 week washout period the groups will be switched.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: mm
3  (1.5) 3  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin, Sugar Pill
Comments Null hypothesis: pre-post brachial artery diameter changes do not differ between placebo and atorvastatin
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments Significance threshold p<0.05
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atorvastatin Sugar Pill
Hide Arm/Group Description Patients are randomized to either atorvastatin or placebo once daily for 12 weeks. There is a 4 week washout, and then the groups are switched for 12 weeks. Brachial artery assessment will be performed before and after each 12 week period on therapy. See above. Patients will be randomized to atorvastatin vs. placebo for 12 weeks and after a 4 week washout period the groups will be switched.
All-Cause Mortality
Atorvastatin Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Atorvastatin Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atorvastatin Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
All patients were enrolled and completed the study interventions and assessments. Technical problems with measurements may have led to some unreliable data.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Doreen DeFaria Yeh
Organization: UCSF
Phone: 617-643-7024
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00767572     History of Changes
Other Study ID Numbers: H7151-32792-01
First Submitted: September 24, 2008
First Posted: October 7, 2008
Results First Submitted: November 9, 2012
Results First Posted: October 14, 2013
Last Update Posted: October 14, 2013